510(k) K070264

50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB by Terumo Europe N.V. — Product Code FMF

K070264 is an FDA 510(k) premarket notification submitted by Terumo Europe N.V. for the device "50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB". The FDA issued a decision of Substantially Equivalent on May 29, 2007. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Terumo Europe N.V. has at least 10 other 510(k) clearances on record.